MAUDE Adverse Event Report: MEDTRONIC, INC. RESOLUTE ONYX¿; CORONARY DRUG-ELUTING STENT

Model Number RONYX35038UX

Device Problems Material Rupture (1546); Activation, Positioning or Separation Problem (2906)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 11/13/2019

Event Type  malfunction  

Event Description

While attempting to deploy a coronary stent in to the right coronary artery, balloon ruptured inside stent before it was opened.Patient became hypotensive and bradycardic requiring iv fluids and atropine.

• Brand Name: RESOLUTE ONYX¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic pkwy; minneapolis MN 55432
• MDR Report Key: 9543892
• MDR Text Key: 173501584
• Report Number: 9543892
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169557130
• UDI-Public: (01)00643169557130
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RONYX35038UX
• Device Lot Number: 0009926856
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23360 DA